MAUDE Adverse Event Report: PROSIDYAN, INC. FIBERGRAFT BG PUTTY; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

After a review of the journal article (samade, r.Et al (2022), utility of 45s5 bioactive glass as bone graft substitute for cavitary defects in pediatric bone tumors: a preliminary study, j pediatr orthop vol.42 (9), pages 532-538 (usa)), it was reported to the manufacturer on march 12, 2024 that one of the 21 patients developed a surgical site infection after treatment of an aneurysmal bone cyst.No additional information was provided about the adverse event.There is no evidence that the infection was due to the product, but this complaint is being reported out of an abundance of caution.

• Brand Name: FIBERGRAFT BG PUTTY
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): PROSIDYAN, INC.; 41 spring st.; suite 107; new providence NJ 07974
• Manufacturer (Section G): PROSIDYAN, INC.; 41 spring st.; suite 107; new providence NJ 07974
• Manufacturer Contact: amanda devine ; 41 spring street; suite 107; new providence, NJ 07974
• MDR Report Key: 19073381
• MDR Text Key: 339738872
• Report Number: 3011015097-2024-00003
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other